Overground Virtual Reality (VR) Gait Rehabilitation for Stroke

ConditionStroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIndiana University

About this trial

The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help stroke survivors improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for stroke survivors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis: Anischemic or hemorrhagic stroke verified by imaging, confirmed by the patient's physician, and 1-6 months post-stroke (subacute phase)

Motor Impairment Level: Functional Ambulation Category (FAC) 3-5, showing moderate impairment while still allowing safe participation in gait tasks.

Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score >= 20, indicating sufficient cognitive function to participate in the study.

Exercise Clearance: Approval from a physician for participation in exercise- and VR-based interventions.

Disqualifiers

Participants with uncontrolled cardiovascular, orthopedic, or metabolic conditions or unstable medication regimens that could interfere with their participation in the study.

Any comorbidity that could interfere with walking or gait training.

Participation in robot- or VR-assisted gait training within the last 6 months.

Intolerance to virtual reality environments or motion simulation.

Trial design

Design model

Parallel

Treatments tested in this trial

Walk-over-Ground
Device
Fully-immersive, real-world environments, overground gait therapy
C-Mill VR+ by Motek
Device
Semi-immersive, game-like environments, treadmill gait therapy

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: VR-Assisted Overground Gait TherapyExperimental treatment 1 intervention

Group B: Conventional Treadmill-Based VR Gait TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Step Count

FitBit tracks the number of steps (count) taken by participant.

Time frame

Continuous tracking from Screening to Week 10

Travel Distance

FitBit tracks the total distance (miles) travelled by participant.

Time frame

Continuous tracking from Screening to Week 10

Activity Zone Minutes

Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak \>70%). Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (\>=70% max HR).

Time frame

Continuous tracking from Screening to Week 10

Secondary outcomes

10-Meter Walk Test

10MWT: Subjects will walk a distance of 10 meters at their normal pace while being timed, allowing assessment of gait speed and mobility.

Time frame

Baseline, Week 7, Week 10

6-Minute Walk Test

6MWT: Subjects will walk for 6 minutes along a 30m track. Subjects may stop and rest as often as needed. Subject walking speed will be collected during the test to evaluate the rate of functional fatigue.

Time frame

Baseline, Week 7, Week 10

Mini-Balance Evaluation Systems Test

Mini-BESTest: Subjects will complete 14 different tasks ranging from static standing to dynamic walking. All subjects will be guarded closely for safety to prevent falling.

Time frame

Baseline, Week 7, Week 10

Timed Up and Go Test

TUG: Subjects will rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. This test is used to assess mobility, balance, walking ability, and fall risk.

Time frame

Baseline, Week 7, Week 10

Other outcomes

Disability Rating Scale

Participants will complete the Disability Rating Scale questionnaire assessing the level of disability and functional impairment. The scale includes 8 items. Scores range from 0 to 29, with 0 indicating no disability and 29 indicating extreme vegetative state; higher scores indicate greater disability and functional impairment.

Time frame

Screening, Baseline, Week 7, Week 10

Stroke Specific Quality of Life Scale

Participants will complete the Stroke Specific Quality of Life Scale assessing health-related quality of life specifically tailored for individuals recovering from stroke. The questionnaire includes 49 items rated from 1 to 5. Scores range from 49 to 245; higher scores indicate better stroke-specific health-related quality of life.

Time frame

Baseline, Week 7, Week 10

Activities-specific Balance Confidence Scale

Participants will complete the Activities-specific Balance Confidence Scale assessing an individual's confidence in maintaining balance while performing common daily activities. The questionnaire includes 16 items rated from 0% to 100%, with 0% indicating no confidence and 100% indicating complete confidence. The total score is calculated as the average of the 16 item scores and ranges from 0% to 100%; higher scores indicate greater balance confidence.

Time frame

Baseline, Week 7, Week 10

Cybersickness in Virtual Reality Questionnaire

Participants will complete the Cybersickness in Virtual Reality Questionnaire assessing physical symptoms associated with VR exposure, including nausea, dizziness, disorientation, imbalance, fatigue, and visual discomfort. The questionnaire includes 6 items rated from 1 to 7. Scores range from 6 to 42; higher scores indicate greater cybersickness symptom intensity.

Time frame

Week 1, Week 4, Week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

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